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WO2002034324A2 - Fil-guide composite - Google Patents

Fil-guide composite Download PDF

Info

Publication number
WO2002034324A2
WO2002034324A2 PCT/US2001/032443 US0132443W WO0234324A2 WO 2002034324 A2 WO2002034324 A2 WO 2002034324A2 US 0132443 W US0132443 W US 0132443W WO 0234324 A2 WO0234324 A2 WO 0234324A2
Authority
WO
WIPO (PCT)
Prior art keywords
core
guidewire
coil
distal end
super elastic
Prior art date
Application number
PCT/US2001/032443
Other languages
English (en)
Other versions
WO2002034324A3 (fr
Inventor
Richard M. Demello
Original Assignee
Radius Medical Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Radius Medical Technologies, Inc. filed Critical Radius Medical Technologies, Inc.
Priority to AU2002224407A priority Critical patent/AU2002224407A1/en
Publication of WO2002034324A2 publication Critical patent/WO2002034324A2/fr
Publication of WO2002034324A3 publication Critical patent/WO2002034324A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A61M25/09033—Guide wires with mandrils with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

Definitions

  • the invention relates generally to guidewires for directing catheters or other medical instruments through the cardiovascular system.
  • PTCA percutaneous transluminal coronary artery angioplasty
  • Stainless steel guidewires are inherently stiff and offer excellent support along the proximal shaft portion of the guidewire.
  • the distal ends of these wires may also be deliberately bent or shaped to aid in steering the guidewire into a particular vessel or lumen.
  • the material is susceptible to further plastic deformation during use and has been known to permanently deform and kink. The deformation is particularly noticeable when the guidewire is manipulated through a tortuous anatomy.
  • guidewires have been made from "super elastic" materials such as Nitinol, with coils added for radiopacity and coatings for lubricity, as mentioned above.
  • the super elastic guidewires offer excellent kink resistance, and provide exceptional torque control when placed within tortuous anatomies.
  • the super elastic mate- rial is significantly less stiff than stainless steel and therefore does not provide a high level of support along the proximal portion of the guidewire.
  • the super elastic material cannot be easily shaped or reshaped at the distal tip to aid in steering the guidewire.
  • Composite construction guidewires combine a proximal portion of stainless steel with a distal portion of super elastic material, to take advantage of the best performance characteristics of both materials.
  • the joint cannot, for example, be held together by braising or welding. Accordingly, a special coupling must be used to lock the materials together.
  • the ends of the two guidewire portions that is, the ends of the two materials
  • a sleeve which made of non- super elastic material
  • the guidewire portions are then held together by crimping, spot welding or gluing the sleeve in place.
  • the coupling relies mainly on the mechanical interface between the two portions of the guidewire. If a mismatch in the cross-sectional dimensions exists, the distal and proximal portions may separate. Further, the repeated torqueing and bending that occurs when the guidewire is manipulated through the cardiovascular system may fatigue the coupling and result in the separation of the distal and proximal portions of the guidewire within the pa- tient's body.
  • a composite guidewire constructed in accordance with the invention includes a solid central core that is made out of super elastic material.
  • a coupling tube which is usually of a non-super elastic material fits over the proximal end of the central core, and a coil, which may be radiopaque, fits over the distal end of the super elastic central core and attaches to a distal end of the coupling tube.
  • a flat safety wire or ribbon of a non-super elastic material that is positioned between the distal portion of the coupling tube and the central core also attaches to the distal end of the coupling tube.
  • the safety wire extends the length of the coil and attaches to both the distal and the proximal ends of the coil.
  • the coil, the coupling tube and the safety wire attach to one another by soldering, brazing, welding or adhesives, which ensures that the joints are strong and the various components of the guidewire do not pull apart.
  • the tube may also be crimped at various locations along its length, to prevent rotational and axial movement between the non-super elastic tube and the super elastic core.
  • An atraumatic tip fits over the end of the guidewire and attaches to the coil and the safety wire by brazing welding or adhesive, to provide a cushioned end.
  • the coil and the safety wire may extend beyond the distal end of the central core, such that the distal end of the guidewire can be readily shaped for steering.
  • the guidewire may also be formed with a composite core that includes the super elastic core and a non-super elastic core extension, which is shaped at its distal end to overlap and mechanically inter-lock with a proximal end of the super elastic core.
  • the coupling tube then extends partially over a portion of the non-super elastic core extension and partially over a portion of the super elastic core, with the proximal end of the coupling tube attaching to the core extension by brazing, welding or adhesives.
  • the coil that fits over the distal end of the super elastic core mates at its proximal end with the distal end of the coupling tube.
  • the safety wire runs from the end of the core extension to distal end of the guidewire, and attaches to the core extension, the coupling tube, the coil and the tip.
  • those ends instead of interlocking the opposing ends of the super elastic core and the non-super elastic core extension, those ends may be butted and the core and core extension provided with longitudinal flats so that the safety wire can extend lengthwise between those elements and the coupling tube. Then the remaining radial space between the core-core extension and the coupling tube is filled with epoxy resin.
  • the epoxy coupled with the irregular cross-sections of the core-to-core extension assembly creates a strong joint able to transmit considerable torque without failure.
  • the various components of the composite guidewire embodiments attach to components of like or similar materials, such that the joints between the components can be formed by brazing, welding or adhesives.
  • the joints are thus strong, and do not fatigue as readily as joints between the dissimilar non-super elastic and super elastic materials that occur in known prior composite guide wires.
  • the guidewire, with its super elastic core takes advantage of the associated resistance to kinking and torque control.
  • the coupling tube overlaid on the super elastic core provides both support for the proximal portion of the guidewire and the ability to shape the distal end of the guidewire.
  • FIG. 1 is a cross-sectional view of a guidewire constructed in accordance with the invention
  • FIG. 2 depicts the guidewire of FIG. 1 with an additional radiopaque coil
  • FIG. 3 depicts the guidewire of FIG. 1 with a radiopaque cover
  • FIG. 4 is a cross-sectional view of an alternative guidewire
  • FIG. 5 is a similar view of another alternative guidewire
  • FIG 6 is a similar view of yet another guidewire embodiment.
  • a composite guidewire 100 includes a central core 12 that is made of super elastic material such as, for example, Nitinol.
  • a coupling tube 16 of a non-super elastic material fits over a proximal portion 13 of the core 12 and attaches at a distal end 22 to a proximal end 19 of a coil 18 that fits over the distal end 14 of the core 12.
  • the coupling tube 16, coil 18 and the safety wire 20 are all of non-super elastic materials, e.g.
  • the tube 16 may also be attached to the super elastic core 12 by crimping at various locations 17, to prevent relative rotational or axial movement.
  • An atraumatic tip 26 that attaches to the distal ends 24 and 28 of the coil 18 and the safety wire 20 may be included, to cushion the distal end 101 of the guidewire 100.
  • the distal end 14 of the core 12 may be tapered for added flexibility at the distal end 101 of the guidewire. Further, the windings 19 of the coil 18 may be slightly spread apart to provide even greater flexibility.
  • the coil 18 may be radiopaque and thus visible to x-rays.
  • the coil 18 may be non-radiopaque and a second shorter coil 30 may be fit over the coil 18 to provide the visibility, as shown in FIG. 2.
  • the coil 18 may be tapered such that the guidewire has a uniform diameter over its length.
  • the radiopacity may instead be provided by a radiopaque plastic cover 32 (FIG.
  • the cover 32 may fit over the tip 26 or may incorporate a cushion and thus replace the tip.
  • the flexibility of the distal end 101 of the guidewire 100 may be further increased by extending the coil 18 and safety wire 20 beyond the distal end 14 of the super elastic core 12.
  • the distal end 101 of the guidewire 100 can thus be readily shaped or bent, to aid in the steering of the guidewire through the body.
  • the proximal end 22 of the central core 12 may be extended beyond the proximal end 15 of the coupling tube 16, such that removable guidewire extensions (not shown) can be fit over the end of the core.
  • the proximal end 22 of the core 12 may be shaped as a stop 23 that further secures the coupling tube 16 against axial movement relative to the core.
  • the guidewire may have a composite core 60 that includes the super elastic core 12 and a core extension 50 of a non-super elastic material, e.g. stainless steel, that fixedly attaches to the super elastic core 12.
  • the extension 50 is shaped at its distal end 52 to mate with a shaped proximal end 54 of the super elastic core 12, such that the core and core extension inter-lock.
  • the outer surface 56 of the distal end 52 of the core extension 50 tapers slightly, to meet the proximal end 15 of the coupling tube 16.
  • Surface 56 tapers to approximately one-half the diameter of the core extension and includes a recess 62 for receiving a tab 64 that extends from an inner surface 66 of the s super elastic core 12.
  • the inner surface 66 of the core 12 tapers to approximately one- half the diameter of the core and includes a recess 68 for receiving a tab 70 that extends from the core extension 50.
  • the tapered ends of the core 12 and the extension 50 thus overlap and inter-lock to produce a composite core 60 of essentially uniform diameter with a mechanically tight joint.
  • the coupling tube 16 extends from the proximal end of the core 12 to meet the proximal end of the coil 18.
  • the coupling tube thus also extends over and attaches to the tapered outer surface 56 of the distal portion 52 of the core extension 50.
  • the safety wire 20 attaches to and extends from a distal end wall 53 of the non-super elastic core extension 50 to the distal end 24 of the coil 18.
  • the safety s wire 201, the coil 18 and the core extension 50 all being of non-super elastic compatible materials may be attached to one another by brazing, welding or adhesives.
  • the coupling tube 20 which overlaps both the core 12 and the extension 50 may be made of super elastic material or non-super elastic material.
  • the coupling tube then attaches to the similar material coil or coil extension by brazing, welding, or adhesives. 0
  • the selection of material for the coupling tube depends on the desired flexibility of the joint portion of the tube.
  • FIG. 6 shows a guidewire with a somewhat different connection between the super elastic core 12 and the non-super elastic core extension 50. Instead of interlocking the opposing ends of those members, they are provided with 5 squared off ends which are butted more or less midway along within the coupling tube 16.
  • the core and core extension are provided with longitudinal flats 12a and 50a, respectively, to provide clearance for the safety wire 20.
  • Wire 20 extends from a point just beyond the proximal end of coupling tube 16 to the distal end of coil 18. 0 Then, the entire remaining space within coupling tube 16 is filled with epoxy resin 80 as shown by the stippling in FIG. 6. Since the core 12 and core extension 50, with their flats, have irregular shapes, the epoxy creates a strong joint between the core and core extension that is able to transmit substantial torque without failure.
  • the non-super elastic components of the guidewire i.e., coil 18, safety wire 20 and tube extension 50 may be connected by welding, brazing, adhesives or the like.
  • the coupling tube 16 which may be made from either super elastic material or non-super elastic material, attaches to the core or the core extension, as appropriate, by welding, brazing, adhesives or the like.
  • the composite guidewire includes a super elastic core and various non-super elastic components.
  • the non-super elastic components which overlay the super elastic core, attach to one another by brazing, welding or adhesives and thus form strong joints between a distal coil, a ribbon wire and a proximal end of the guidewire, and as appropriate, a non-super elastic coupling tube that extends over the proximal end of the super elastic core.
  • the coupling tube and/or the non-super elastic core extension provides support for the proximal end of the guidewire, while the safety wire and coil provide a flexible and shapeable distal end. Accordingly, the guidewire combines the best qualities of non-super elastic and super elastic materials without sacrificing joint strength.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un fil-guide composite comportant une âme centrale solide en matériau superélastique, et une ou plusieurs surcouches de matériau non superélastique. Selon l'invention, un tube de couplage vient se placer sur l'extrémité proximale de l'âme, et une bobine opacifiante vient se placer sur l'extrémité distale de l'âme et se fixe sur une extrémité distale du tube de couplage. Un fil de sécurité plat disposé entre la partie distale du tube de couplage et l'âme se fixe également sur l'extrémité distale du tube. Ce fil de sécurité prolonge la bobine et se fixe sur les extrémités proximale et distale de la bobine. La bobine, le tube de couplage et le fil de sécurité tous réalisés en matériau non superélastique peuvent être reliés les uns aux autres par jointage, brasage, soudage ou collage. Le tube de couplage peut également être pincé à différents endroits sur sa longueur de manière à empêcher rotation relative et mouvements axiaux du tube par rapport à l'âme superélastique. Une pointe non traumatique venant se placer sur l'extrémité du fil-guide et se fixer sur la bobine et le fil de sécurité par brasage, soudage ou collage peut servir de coussinet sur l'extrémité distale du fil-guide. La bobine et le fil de sécurité peuvent s'étendre au-delà de l'extrémité distale de l'âme centrale de manière que l'extrémité distale du fil-guide puisse être formée. L'extrémité proximale du fil-guide peut également être formée avec une extension de l'âme non superélastique formée sur son extrémité distale de manière à chevaucher et verrouiller mécaniquement une extrémité proximale de l'âme. Le tube de couplage s'étend ensuite partiellement sur l'extension de l'âme non superélastique et partiellement sur l'âme superélastique, l'extrémité proximale du tube de couplage étant fixée à l'âme d'extension par brasage, soudage ou collage. Le fil de sécurité se fixe à l'extension de l'âme et s'étend au dessus de l'âme superélastique vers l'extrémité distale du fil-guide. La bobine venant se placer sur l'extrémité distale de l'âme se fixe au fil de sécurité et au tube de couplage, tout comme une pointe formant l'extrémité du fil-guide.
PCT/US2001/032443 2000-10-20 2001-10-18 Fil-guide composite WO2002034324A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002224407A AU2002224407A1 (en) 2000-10-20 2001-10-18 Composite guidewire

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US69354700A 2000-10-20 2000-10-20
US09/693,547 2000-10-20
US09/778,566 US6544197B2 (en) 2000-10-20 2001-02-07 Composite guidewire
US09/778,566 2001-02-07

Publications (2)

Publication Number Publication Date
WO2002034324A2 true WO2002034324A2 (fr) 2002-05-02
WO2002034324A3 WO2002034324A3 (fr) 2002-08-08

Family

ID=27105198

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/032443 WO2002034324A2 (fr) 2000-10-20 2001-10-18 Fil-guide composite

Country Status (3)

Country Link
US (1) US6544197B2 (fr)
AU (1) AU2002224407A1 (fr)
WO (1) WO2002034324A2 (fr)

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JP4312875B2 (ja) 1998-08-28 2009-08-12 株式会社パイオラックス 医療用ガイドワイヤ及びその製造方法

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004075963A1 (fr) * 2003-02-26 2004-09-10 Boston Scientific Limited Instrument medical intracorporel allonge
WO2004075967A1 (fr) * 2003-02-26 2004-09-10 Boston Scientific Limited Dispositif medical intracorporel de forme allongee
WO2004075968A1 (fr) * 2003-02-26 2004-09-10 Boston Scientific Limited Dispositif mediccal intracorporel allonge
JP2006519072A (ja) * 2003-02-26 2006-08-24 ボストン サイエンティフィック リミテッド 長尺状体内医療器具
US7182735B2 (en) 2003-02-26 2007-02-27 Scimed Life Systems, Inc. Elongated intracorporal medical device
US7316656B2 (en) 2003-02-26 2008-01-08 Boston Scientific Scimed, Inc. Elongated intracorporal medical device
JP4808611B2 (ja) * 2003-02-26 2011-11-02 ボストン サイエンティフィック リミテッド 長尺状体内医療器具
US8222566B2 (en) 2003-02-26 2012-07-17 Boston Scientific Scimed, Inc. Elongated intracorporal medical device

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US6544197B2 (en) 2003-04-08
AU2002224407A1 (en) 2002-05-06
WO2002034324A3 (fr) 2002-08-08
US20020049392A1 (en) 2002-04-25

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